Among 918 children aged 6-60 months presenting with gastroenteritis-associated vomiting and dehydration at pediatric emergency departments in Pakistan, 462 children were randomly assigned to receive a single dose of oral ondansetron while 456 children received a placebo. The primary outcome was intravenous rehydration administered within 72 hours. Fewer children who received ondansetron (14.7%) required intravenous rehydration compared to those who received placebo (19.5%), and multivariable analysis found lower odds of intravenous rehydration for children who received ondansetron. Children who received ondansetron also experienced less vomiting during the observation period. The study concludes that oral ondansetron administration safely reduces intravenous
Cooked green banana diet in addition to standard treatment reduces the duration of acute watery diarrhea and lessens the chances of complications like dehydration in children under five years of age, according to this randomized controlled trial. The trial found that children who received cooked green banana had faster recovery times and lower rates of persistent diarrhea compared to those receiving only standard treatment.
Teduglutida en el síndrome de intestino corto. Experiencia en PediatríaJavier González de Dios
Teduglutide seems to be a safe and effective treatment for pediatric short bowel syndrome (SBS) based on a study of 17 pediatric patients treated with teduglutide. 12 out of 17 patients achieved independence from parenteral nutrition, with 3 patients weaning after 3 months, 4 after 6 months, and 5 after 12 months. Teduglutide treatment also decreased parenteral nutrition requirements by 50% in most other patients. Only one patient did not see improvements. Adverse effects were generally mild, with one episode each of cholecystitis and cardiac decompensation in patients with pre-existing conditions.
Comparison of prolonged low volume milk and routine volume milk onamir mohammad Armanian
This study compared outcomes for very low birth weight neonates who were fed using either a prolonged low volume milk strategy (20 mL/kg/day for 7 days before increasing) or a routine advancing volume strategy (increasing volumes by 20 mL/kg/day). The study found that the incidence of necrotizing enterocolitis was significantly lower in infants fed with the prolonged low volume strategy compared to those fed with advancing volumes. However, infants fed with advancing volumes reached full enteral feeding volumes sooner. Overall hospital stay times and weight gain at 30 days were similar between the two groups. The study suggests prolonged low volume feeding may help reduce NEC risk in very low birth weight neonates.
This document summarizes a study that assessed the impact of supplementing the diets of severely malnourished children in Burkina Faso with Moringa oleifera leaf powder. 110 children aged 6-59 months were randomly assigned to two groups. Both groups received standard nutritional care, but one group received an additional 10g per day of Moringa leaf powder. Children receiving the Moringa supplement had higher average weight gain, a quicker recovery rate, but no significant difference in hemoglobin levels. The Moringa supplementation was found to be effective and safe in improving the nutritional recovery of severely malnourished children.
Prevalence of diarrhea among severely malnourished children admitted in Gover...Open Access Research Paper
Mortality rate of children under the age of five has reduced worldwide, but still the probability of a child dying before the age of five is greatest in underdeveloped countries. Pakistan reports child mortality rates in same bracket as other South Asian countries due to malnutrition and diarrhea. To determine the prevalence and factors associated in children less than five years of age a cross sectional study was conducted with mothers whose children were admitted in pediatric government Hospital, Lahore. A convenient sample of 101 children (6-59 months, 53 males and 48 females) suffering from malnutrition and diarrhea were selected from hospital. Data about socio demographic, anthropometric, clinical and dietary variables were collected and analyzed by using SPSS version 16. The results showed that mean age of patients was 19.36 ± 10.5 months. The illiteracy rate among mother and father of patients was 94.1% and 69.3% respectively. 94.1% of the patients were breastfed while 47.5% of the patients were on bottle feed with breast milk. 66.3% patients families has very low-income rate while 33.7% were satisfactory. 40.6% patients were not vaccinated against immunization. Out of 101 patients, 39.6% of the patients had diarrhea while 6.9% of the patients had chronic diarrhea. The prevalence rate of diarrhea (39%) was less among children who were younger than 18 months as compared to those who were above 18 months (40.5%). The most significant factors that caused the incidence of diarrhea in children was form of water storage system, complementary feeding practices, and hand wash cleaning materials. This study concluded that government, nongovernmental organizations and families living with children and mothers could cooperate on strategies to minimize the risks of the diarrhea among children less than five years of age.
The study evaluated the efficacy of using P&G Purifier of Water for point-of-use water treatment compared to no water treatment in the nutrition treatment of severe acute malnutrition in children under 5 in the Democratic Republic of Congo. It found that children who received Ready-to-Use Therapeutic Food and had their water treated with P&G Purifier of Water had a shorter average treatment time (26.4 vs 30.4 days) and a lower prevalence of waterborne diseases compared to those who only received Ready-to-Use Therapeutic Food. Additionally, the cost of the additional water treatment was offset by the reduction in treatment time. The study supports promoting P&G Purifier of Water as part of standard malnutrition
Severe acute malnutrition remains a major cause of childhood mortality worldwide, with 19 million preschool children affected each year. While treatment guidelines have incorporated ready-to-use therapeutic foods and antibiotics in outpatient settings, some children still fail to recover. A 2013 study found that adding amoxicillin or cefdinir to outpatient treatment significantly improved recovery rates. However, a 2016 study found no clear benefit of routine antibiotic use and raised concerns about increasing antibiotic resistance, calling for further research before changing treatment guidelines.
Cooked green banana diet in addition to standard treatment reduces the duration of acute watery diarrhea and lessens the chances of complications like dehydration in children under five years of age, according to this randomized controlled trial. The trial found that children who received cooked green banana had faster recovery times and lower rates of persistent diarrhea compared to those receiving only standard treatment.
Teduglutida en el síndrome de intestino corto. Experiencia en PediatríaJavier González de Dios
Teduglutide seems to be a safe and effective treatment for pediatric short bowel syndrome (SBS) based on a study of 17 pediatric patients treated with teduglutide. 12 out of 17 patients achieved independence from parenteral nutrition, with 3 patients weaning after 3 months, 4 after 6 months, and 5 after 12 months. Teduglutide treatment also decreased parenteral nutrition requirements by 50% in most other patients. Only one patient did not see improvements. Adverse effects were generally mild, with one episode each of cholecystitis and cardiac decompensation in patients with pre-existing conditions.
Comparison of prolonged low volume milk and routine volume milk onamir mohammad Armanian
This study compared outcomes for very low birth weight neonates who were fed using either a prolonged low volume milk strategy (20 mL/kg/day for 7 days before increasing) or a routine advancing volume strategy (increasing volumes by 20 mL/kg/day). The study found that the incidence of necrotizing enterocolitis was significantly lower in infants fed with the prolonged low volume strategy compared to those fed with advancing volumes. However, infants fed with advancing volumes reached full enteral feeding volumes sooner. Overall hospital stay times and weight gain at 30 days were similar between the two groups. The study suggests prolonged low volume feeding may help reduce NEC risk in very low birth weight neonates.
This document summarizes a study that assessed the impact of supplementing the diets of severely malnourished children in Burkina Faso with Moringa oleifera leaf powder. 110 children aged 6-59 months were randomly assigned to two groups. Both groups received standard nutritional care, but one group received an additional 10g per day of Moringa leaf powder. Children receiving the Moringa supplement had higher average weight gain, a quicker recovery rate, but no significant difference in hemoglobin levels. The Moringa supplementation was found to be effective and safe in improving the nutritional recovery of severely malnourished children.
Prevalence of diarrhea among severely malnourished children admitted in Gover...Open Access Research Paper
Mortality rate of children under the age of five has reduced worldwide, but still the probability of a child dying before the age of five is greatest in underdeveloped countries. Pakistan reports child mortality rates in same bracket as other South Asian countries due to malnutrition and diarrhea. To determine the prevalence and factors associated in children less than five years of age a cross sectional study was conducted with mothers whose children were admitted in pediatric government Hospital, Lahore. A convenient sample of 101 children (6-59 months, 53 males and 48 females) suffering from malnutrition and diarrhea were selected from hospital. Data about socio demographic, anthropometric, clinical and dietary variables were collected and analyzed by using SPSS version 16. The results showed that mean age of patients was 19.36 ± 10.5 months. The illiteracy rate among mother and father of patients was 94.1% and 69.3% respectively. 94.1% of the patients were breastfed while 47.5% of the patients were on bottle feed with breast milk. 66.3% patients families has very low-income rate while 33.7% were satisfactory. 40.6% patients were not vaccinated against immunization. Out of 101 patients, 39.6% of the patients had diarrhea while 6.9% of the patients had chronic diarrhea. The prevalence rate of diarrhea (39%) was less among children who were younger than 18 months as compared to those who were above 18 months (40.5%). The most significant factors that caused the incidence of diarrhea in children was form of water storage system, complementary feeding practices, and hand wash cleaning materials. This study concluded that government, nongovernmental organizations and families living with children and mothers could cooperate on strategies to minimize the risks of the diarrhea among children less than five years of age.
The study evaluated the efficacy of using P&G Purifier of Water for point-of-use water treatment compared to no water treatment in the nutrition treatment of severe acute malnutrition in children under 5 in the Democratic Republic of Congo. It found that children who received Ready-to-Use Therapeutic Food and had their water treated with P&G Purifier of Water had a shorter average treatment time (26.4 vs 30.4 days) and a lower prevalence of waterborne diseases compared to those who only received Ready-to-Use Therapeutic Food. Additionally, the cost of the additional water treatment was offset by the reduction in treatment time. The study supports promoting P&G Purifier of Water as part of standard malnutrition
Severe acute malnutrition remains a major cause of childhood mortality worldwide, with 19 million preschool children affected each year. While treatment guidelines have incorporated ready-to-use therapeutic foods and antibiotics in outpatient settings, some children still fail to recover. A 2013 study found that adding amoxicillin or cefdinir to outpatient treatment significantly improved recovery rates. However, a 2016 study found no clear benefit of routine antibiotic use and raised concerns about increasing antibiotic resistance, calling for further research before changing treatment guidelines.
Eating habits and nutritional status among adolescent school girls: an experi...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
4--Child health care and preventive pediatrics{4}.pptShamiPokhrel2
This document discusses various feeding problems in infants during the first two years of life, including underfeeding, overfeeding, regurgitation and vomiting, constipation, and feeding during the second year. It provides information on causes and treatments for each issue. For example, it states that underfeeding may be caused by problems with feeding mechanics or bonding, and overfeeding can result from high-fat or high-carbohydrate diets. It also outlines recommendations for healthy eating habits and snacks as infants age.
How to improve enteral feeding tolerance in chronically critically ill patientsDr Jay Prakash
These interruptions to EN result in significant daily and cumulative calorie deficits, thus contributing to underfeeding and malnutrition. Underfed patients have an increased risk of all-cause mortality, bloodstream infections and longer ICU and hospital stays.
Effects of moderate doses of vitamin A as an adjunct to the treatment of pneu...ISAMI1
Effects of moderate doses of vitamin A as an adjunct to the treatment of pneumonia in underweight and normal-weight children: a randomized, double-blind, placebo-controlled trial
The efficacy of domperidone in the treatment of childhood gerdFaisal Wahid
This study investigated the efficacy and side effects of domperidone in treating gastroesophageal reflux disease in 220 children between 1 month and 15 years old over a period of 3 years. Domperidone was found to effectively treat symptoms in 85.5% of children with few side effects. The most common side effect was loose stool in 15% of children. There was no significant relationship between treatment response and factors like age, sex, or clinical symptoms. This study suggests that domperidone is an effective and well-tolerated treatment for reflux in children regardless of age or sex.
The document discusses various treatments for acute diarrhea in children. It begins by noting that diarrhea remains a significant cause of illness and death in children under 5 years old worldwide. It then reviews several treatment options including oral rehydration therapy (ORT), lactose-free formulas, the clay mineral diosmectite, the antisecretory drug racecadotril, zinc supplementation, and probiotics. For each treatment, it summarizes available evidence on effectiveness and safety from studies and reviews. The document emphasizes that ORT is the recommended first-line treatment for rehydration and that there is insufficient evidence to recommend routine use of other treatments, though some like zinc may provide benefit in specific cases.
- Functional constipation, which accounts for 95% of cases in children and adolescents, is diagnosed based on the Rome IV criteria through a history and physical exam without additional testing.
- Common treatments for functional constipation include polyethylene glycol (Miralax), lactulose, and enemas. Increasing fiber/fluid intake and probiotics are not effective treatments.
- Referrals to a psychologist can help with some treatment goals, like improving a child's quality of life negatively impacted by chronic constipation. Managing constipation requires addressing relapses and potentially long-term therapy.
A 9-month-old male infant presented with gastroenteritis and dehydration. He was experiencing vomiting, diarrhea, and weight loss. Initial assessments found tachycardia, poor skin turgor, and signs of dehydration. Lab work showed anemia and elevated white blood cell count, indicating infection. The infant was admitted and started on IV fluids and antibiotics to treat the infection and rehydrate him. Nursing care focused on monitoring fluid intake and output, vital signs, and symptoms to manage the diarrhea and prevent further dehydration.
The document discusses an epidemiological study on worm infestation in Surkhet district, Nepal. It provides background on common types of worms that can infect humans. Worm infestation is a major public health problem, especially among children, due to poor sanitation and hygiene. The study aims to understand the epidemiology of worm infestation in the district by examining factors like time, place, and person. Secondary data from the past 3 years will be reviewed to analyze trends and distributions of worm infestation cases. The findings will help authorities better plan prevention and treatment services.
Eating habits and nutritional status among adolescent school girls: an experi...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
- Drug dosage in pediatric patients is influenced by the unique physiology of childhood including rapid growth and development which affects pharmacokinetics.
- Factors like absorption, distribution, metabolism and excretion differ in children compared to adults and influence the pharmacokinetic profile of drugs.
- Common analgesics used in pediatric patients include paracetamol, ibuprofen, and naproxen, with paracetamol being the first line for mild to moderate pain.
Nutritional Status of School Age Children in Private Elementary Schools: Basi...IJAEMSJORNAL
Department of Education (DepEd) organizes nutritional programs to improve the health status of children in public schools. Likewise, the researcher believes that health awareness must be raised in private schools as well. This study aimed to affect the community to be aware and more knowledgeable about nutrition. Specifically, this study focused on the nutritional status of school age children in private elementary schools in Santa Rosa, Nueva Ecija. It sought to determine the profile of the learners, anthropometrics, clinical data and the knowledge of the learners as to dietary and the significant relationship between the profile of the learners and the nutritional status of the school aged children. With all the data gathered a meal management program was proposed. The study employed the quantitative description design. The study manifests that majority of the respondents were not yet aware of what they eat. In addition, age, greatly affects the respondent’s anthropometrics as to height. More so, age, number of siblings and family income, greatly affect the respondents’ anthropometrics as to weight. The researcher adopted the Nutritional Guidelines for Filipino program that was developed by the DOST- FNRI.
Assessment of Mothers' Knowledge and use of Oral Rehydration Therapy for Dia...GABRIEL JEREMIAH ORUIKOR
Diarrhoea disease is the second leading cause of death in
children under 5 years old, and is responsible for killing about 300, 000
children annually in Nigeria. Oral rehydration therapy (ORT) is the preferred
treatment for fluid and electrolyte losses due to diarrhoea in children with
mild to moderate dehydration. This study aimed to assess the knowledge
and use of ORT in the management of diarrhoea in children under 5 years
at Seventh Day Adventist Hospital (SDAH, Ife).
A Prospective Observational Study of Zinc As Adjunct Therapy In Pediatric Pop...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document provides clinical practice guidelines for the management of community-acquired pneumonia (CAP) in infants and children older than 3 months. It includes recommendations on site-of-care management decisions, diagnostic testing, antimicrobial and surgical therapy, and prevention. The expert panel developed evidence-based guidelines to assist clinicians in decreasing the morbidity and mortality of CAP in children. The guidelines cover practical questions of diagnosis and treatment of CAP in both outpatient and inpatient settings.
Comparative Studies of Knowledge and Perception of Parents on Home Management...inventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Eating habits and nutritional status among adolescent school girls: an experi...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
4--Child health care and preventive pediatrics{4}.pptShamiPokhrel2
This document discusses various feeding problems in infants during the first two years of life, including underfeeding, overfeeding, regurgitation and vomiting, constipation, and feeding during the second year. It provides information on causes and treatments for each issue. For example, it states that underfeeding may be caused by problems with feeding mechanics or bonding, and overfeeding can result from high-fat or high-carbohydrate diets. It also outlines recommendations for healthy eating habits and snacks as infants age.
How to improve enteral feeding tolerance in chronically critically ill patientsDr Jay Prakash
These interruptions to EN result in significant daily and cumulative calorie deficits, thus contributing to underfeeding and malnutrition. Underfed patients have an increased risk of all-cause mortality, bloodstream infections and longer ICU and hospital stays.
Effects of moderate doses of vitamin A as an adjunct to the treatment of pneu...ISAMI1
Effects of moderate doses of vitamin A as an adjunct to the treatment of pneumonia in underweight and normal-weight children: a randomized, double-blind, placebo-controlled trial
The efficacy of domperidone in the treatment of childhood gerdFaisal Wahid
This study investigated the efficacy and side effects of domperidone in treating gastroesophageal reflux disease in 220 children between 1 month and 15 years old over a period of 3 years. Domperidone was found to effectively treat symptoms in 85.5% of children with few side effects. The most common side effect was loose stool in 15% of children. There was no significant relationship between treatment response and factors like age, sex, or clinical symptoms. This study suggests that domperidone is an effective and well-tolerated treatment for reflux in children regardless of age or sex.
The document discusses various treatments for acute diarrhea in children. It begins by noting that diarrhea remains a significant cause of illness and death in children under 5 years old worldwide. It then reviews several treatment options including oral rehydration therapy (ORT), lactose-free formulas, the clay mineral diosmectite, the antisecretory drug racecadotril, zinc supplementation, and probiotics. For each treatment, it summarizes available evidence on effectiveness and safety from studies and reviews. The document emphasizes that ORT is the recommended first-line treatment for rehydration and that there is insufficient evidence to recommend routine use of other treatments, though some like zinc may provide benefit in specific cases.
- Functional constipation, which accounts for 95% of cases in children and adolescents, is diagnosed based on the Rome IV criteria through a history and physical exam without additional testing.
- Common treatments for functional constipation include polyethylene glycol (Miralax), lactulose, and enemas. Increasing fiber/fluid intake and probiotics are not effective treatments.
- Referrals to a psychologist can help with some treatment goals, like improving a child's quality of life negatively impacted by chronic constipation. Managing constipation requires addressing relapses and potentially long-term therapy.
A 9-month-old male infant presented with gastroenteritis and dehydration. He was experiencing vomiting, diarrhea, and weight loss. Initial assessments found tachycardia, poor skin turgor, and signs of dehydration. Lab work showed anemia and elevated white blood cell count, indicating infection. The infant was admitted and started on IV fluids and antibiotics to treat the infection and rehydrate him. Nursing care focused on monitoring fluid intake and output, vital signs, and symptoms to manage the diarrhea and prevent further dehydration.
The document discusses an epidemiological study on worm infestation in Surkhet district, Nepal. It provides background on common types of worms that can infect humans. Worm infestation is a major public health problem, especially among children, due to poor sanitation and hygiene. The study aims to understand the epidemiology of worm infestation in the district by examining factors like time, place, and person. Secondary data from the past 3 years will be reviewed to analyze trends and distributions of worm infestation cases. The findings will help authorities better plan prevention and treatment services.
Eating habits and nutritional status among adolescent school girls: an experi...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
- Drug dosage in pediatric patients is influenced by the unique physiology of childhood including rapid growth and development which affects pharmacokinetics.
- Factors like absorption, distribution, metabolism and excretion differ in children compared to adults and influence the pharmacokinetic profile of drugs.
- Common analgesics used in pediatric patients include paracetamol, ibuprofen, and naproxen, with paracetamol being the first line for mild to moderate pain.
Nutritional Status of School Age Children in Private Elementary Schools: Basi...IJAEMSJORNAL
Department of Education (DepEd) organizes nutritional programs to improve the health status of children in public schools. Likewise, the researcher believes that health awareness must be raised in private schools as well. This study aimed to affect the community to be aware and more knowledgeable about nutrition. Specifically, this study focused on the nutritional status of school age children in private elementary schools in Santa Rosa, Nueva Ecija. It sought to determine the profile of the learners, anthropometrics, clinical data and the knowledge of the learners as to dietary and the significant relationship between the profile of the learners and the nutritional status of the school aged children. With all the data gathered a meal management program was proposed. The study employed the quantitative description design. The study manifests that majority of the respondents were not yet aware of what they eat. In addition, age, greatly affects the respondent’s anthropometrics as to height. More so, age, number of siblings and family income, greatly affect the respondents’ anthropometrics as to weight. The researcher adopted the Nutritional Guidelines for Filipino program that was developed by the DOST- FNRI.
Assessment of Mothers' Knowledge and use of Oral Rehydration Therapy for Dia...GABRIEL JEREMIAH ORUIKOR
Diarrhoea disease is the second leading cause of death in
children under 5 years old, and is responsible for killing about 300, 000
children annually in Nigeria. Oral rehydration therapy (ORT) is the preferred
treatment for fluid and electrolyte losses due to diarrhoea in children with
mild to moderate dehydration. This study aimed to assess the knowledge
and use of ORT in the management of diarrhoea in children under 5 years
at Seventh Day Adventist Hospital (SDAH, Ife).
A Prospective Observational Study of Zinc As Adjunct Therapy In Pediatric Pop...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document provides clinical practice guidelines for the management of community-acquired pneumonia (CAP) in infants and children older than 3 months. It includes recommendations on site-of-care management decisions, diagnostic testing, antimicrobial and surgical therapy, and prevention. The expert panel developed evidence-based guidelines to assist clinicians in decreasing the morbidity and mortality of CAP in children. The guidelines cover practical questions of diagnosis and treatment of CAP in both outpatient and inpatient settings.
Comparative Studies of Knowledge and Perception of Parents on Home Management...inventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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1. Oral Ondansetron Administration to
Dehydrated Children in Pakistan: A
Randomized Clinical Trial
Stephen B. Freedman, MDCM, MSc,a
Sajid B. Soofi, FCPS,c
Andrew R. Willan, PhD,d
Sarah Williamson-Urquhart, BScKIN,b
Emaduddin Siddiqui, FCPS,c
Jianling Xie, MD,b
Fady Dawoud, MD,b
Zulfiqar A. Bhutta, PhDc,e
abstract
BACKGROUND: Ondansetron is an effective antiemetic employed to prevent vomiting in children
with gastroenteritis in high-income countries; data from low- and middle-income countries
are sparse.
METHODS: We conducted a randomized, double-blind, placebo-controlled superiority trial in 2
pediatric emergency departments in Pakistan. Dehydrated children aged 6 to 60 months with
$1 diarrheal (ie, loose or liquid) stool and $1 vomiting episode within the preceding 4 hours
were eligible to participate. Participants received a single weight-based dose of oral
ondansetron (8–15 kg: 2 mg; .15 kg: 4 mg) or identical placebo. The primary outcome was
intravenous administration of $20 mL/kg over 4 hours of an isotonic fluid within 72 hours of
random assignment.
RESULTS: All 918 (100%) randomly assigned children completed follow-up. Intravenous
rehydration was administered to 14.7% (68 of 462) and 19.5% (89 of 456) of those
administered ondansetron and placebo, respectively (difference: 24.8%; 95% confidence
interval [CI], 29.7% to 0.0%). In multivariable logistic regression analysis adjusted for other
antiemetic agents, antibiotics, zinc, and the number of vomiting episodes in the preceding
24 hours, children administered ondansetron had lower odds of the primary outcome (odds
ratio: 0.70; 95% CI, 0.49 to 1.00). Fewer children in the ondansetron, relative to the placebo
group vomited during the observation period (difference: 212.9%; 95% CI, 218.0% to
27.8%). The median number of vomiting episodes (P , .001) was lower in the
ondansetron group.
CONCLUSIONS: Among children with gastroenteritis-associated vomiting and dehydration, oral
ondansetron administration reduced vomiting and intravenous rehydration use. Ondansetron
use may be considered to promote oral rehydration therapy success among dehydrated
children in low- and middle-income countries.
WHAT’S KNOWN ON THIS SUBJECT: Ondansetron administration to dehydrated
children with gastroenteritis-associated vomiting in emergency departments in
high-income countries reduces vomiting and intravenous rehydration. Although it
is ineffective among well-hydrated children, evidence of efficacy in dehydrated
children in low- and middle-income countries is lacking.
WHAT THIS STUDY ADDS: Emergency department oral ondansetron administration
to dehydrated children with gastroenteritis-associated vomiting in Pakistan safely
reduces intravenous rehydration fluid administration and vomiting, and it should
be considered to promote oral rehydration therapy in this population.
To cite: Freedman SB, Soofi SB, Willan AR, et al. Oral
Ondansetron Administration to Dehydrated Children in
Pakistan: A Randomized Clinical Trial. Pediatrics. 2019;
144(6):e20192161
a
Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children’s
Hospital and Alberta Children’s Hospital Research Institute and b
Section of Pediatric Emergency Medicine,
Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; c
Centre of
Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan; d
Ontario Child Health Support
Unit, SickKids Research Institute, Toronto, Ontario, Canada; and e
Centre for Global Child Health, The Hospital for
Sick Children, Toronto, Ontario, Canada
This work was presented at the annual meeting of the Pediatric Academic Societies; April 24, 2019,
to May 1, 2019; Baltimore, MD.
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2. Globally, nearly 6 million children
,5 years of age still die annually.1
Despite advances in oral rehydration
therapy (ORT) and treatment of
diarrhea, some 500 000 of these
deaths are due to acute
gastroenteritis (AGE).1
Important
contributors to diarrhea-related
mortality include limited access to
services and the stagnated use of
ORT,2,3
particularly in the presence of
vomiting. In Pakistan, 80% of those
who develop severe dehydration have
persistent vomiting, with a high
frequency in the first 6 hours of
therapy.4
Although use of antiemetic
agents such as domperidone or
metoclopramide is commonplace,5,6
they are of limited benefit.7,8
A single oral dose of ondansetron
reduces vomiting and intravenous
rehydration use.9,10
Although
administration in high-income
countries is widespread,11–13
research on its use in low- and
middle-income countries (LMICs) is
limited but is necessary given the
differences in etiology, clinical
phenotypes,14
and complications.5
Consequently, there is a need to
determine if ondansetron can
enhance ORT success in a LMIC
setting.
We conducted 2 separate but linked
studies in Karachi Pakistan6
to answer
2 questions, and we planned a priori
to publish 2 unique reports. In the first
study, we reported that among
children without dehydration,15
there
were no benefits associated with
ondansetron use. In the second study,
we evaluated whether a single oral
ondansetron dose administered to
children with vomiting and
dehydration secondary to AGE reduces
the probability of intravenous
rehydration fluid administration
compared to the placebo.
METHODS
Design and Setting
We performed a 2-center, randomized,
double-blind, placebo-controlled
superiority trial (Fig 1) in the
emergency departments (EDs) of The
Aga Khan University Hospital for
Women and Children and The Aga
Khan University Hospital, Karachi,
Pakistan. Pediatric emergency
medicine trained physicians treat
∼10 000 and 5000 patients annually in
each of these institutions, respectively.
The study was approved by the ethics
committees of The Aga Khan
University and University of Calgary.
Study Population
Potentially eligible children were
consecutively screened by study-
funded research officers 24 hours/
day, 7 days/week. Eligible children
were aged 0.5 to 5.0 years, weighed
$8.0 kg, and had $1 episode of
diarrhea (ie, a minimum of 1 loose or
liquid stool) and $1 vomiting episode
within the 4 hours preceding triage.13
As previously performed,13
we
employed lower age and weight limits
because infants ,6 months of age are
more likely to have alternative
underlying etiologies (eg, urinary
tract infection), and 8.0 kg
corresponds to the weight at which
the smallest study dose (2 mg) can be
administered. Participants had
FIGURE 1
Consolidated Standards of Reporting Trials flow diagram. a
weight for height below -3z scores of the
median WHO growth standards. b
The one child that was lost to follow-up had complete data for 4
hour emergency department observation period. The child was included in the primary analysis as
he received . 20 ml/kg of intravenous fluids and thus experienced the outcome of interest.
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3. “some” dehydration quantified by
using the World Health Organization
(WHO) dehydration tool,16,17
which
requires the presence of $2 of the
following: restlessness and/or
irritability, sunken eyes, drinking
eagerly and/or thirst, and skin pinch
retracts slowly.16
Children with the following were
excluded: severe dehydration, bloody
or bilious vomiting, hypotension,18
vomiting or diarrhea for .7 days,
previous abdominal surgery,
hypersensitivity to ondansetron or
any serotonin receptor antagonist,
personal or family history of
prolonged QT syndrome, taking
a medication listed as causing
torsades de pointes (https://
crediblemeds.org/index.php/login/
dlcheck:), previously enrolled in the
study, and those for whom follow-up
would not be possible. We excluded
children whose weight for height was
,23 z scores of the median WHO
growth standards because children
with malnutrition are at greater risk
of electrolyte abnormalities.19
Guardians of all participants provided
written informed consent.
Allocation
Children were randomly assigned to
receive a single ondansetron or
placebo oral disintegrating tablet
(ODT; both provided in-kind by
GlaxoSmithKline, Inc, Philadelphia,
PA) in a 1:1 ratio, stratified by age
(,18 and $18 months) and study
center by using variable block sizes of
4 and 6. Use of an Internet-based
randomization service facilitated
allocation concealment. The study
team was unaware of block sizes.
As is commonly performed in clinical
practice20
and trials,13
doses were
weight based: 8 to 15 kg received
a dose of 2 mg; .15 kg received
a dose of 4 mg. Within the dose range
of 0.13 to 0.26 mg/kg, higher doses of
ondansetron are not superior to
lower doses nor are they associated
with increased side effects.21
The
ODT was placed on the top of each
child’s tongue, and the child was
instructed to swallow 5 seconds
later.13
Fifteen minutes after ODT
administration, ORT was initiated.
Children who vomited $1 times
during that interval received a repeat
dose.13
Blinded individuals included
the ED physicians, research officers,
families, patients, and on-site
pharmacists. The placebo and active
ODTs were of identical size,
appearance, taste, and smell.13
A prespecified computer-generated
randomization list with associated kit
numbers was sent from www.
randomize.net via password-
protected files to the research
pharmacist who prepared, packed,
and shipped all drug kits. At
enrollment, www.randomize.net
randomly selected a kit number from
the remaining kits containing the
assigned treatment. Each kit
contained two 4-mg ondansetron or
placebo ODTs (cut in half if needed to
provide a 2-mg dose) including 1
extra dose in case a repeat dose was
required. If the extra dose was
vomited, no additional medications
were provided.
Study Interventions
Aside from study interventions,
participants received therapy in
keeping with WHO recommendations.
Concomitant medication
administration was at the discretion
of the clinical team. The protocol
emphasized a targeted weight-based
ORT protocol during the 4-hour
observation period and caregiver
education regarding oral rehydration
solution (ORS) administration.
Breastfeeding continued ad lib in
addition to giving WHO ORS. If the
child vomited, caregivers waited
10 minutes and then resumed giving
ORS more slowly. Children whose
dehydration, assessed by using the
WHO tool, had resolved were
discharged; those with some
dehydration after 4 hours had ORT
treatment repeated for another
4 hours with food administration.
Should children deteriorate and
develop “severe” dehydration, rapid
intravenous rehydration was
administered.12,21
The need for
hospitalization was determined by
the treating physician. Postdischarge
care was in keeping with WHO
recommendations.16
Caregivers
whose children were suitable for
discharge were provided with a 2-day
supply of ORS and were instructed to
give as much fluid as the child desired
to prevent dehydration. To reduce the
likelihood of persistent diarrhea,
participants were also provided with
a 2-week supply of 20-mg zinc tablets
to be administered daily for 14
days.22
Caregivers were instructed to
initiate zinc therapy a minimum of
30 minutes after study drug
administration.
Data
Data were collected by research
officers. During the 4-hour study
observation period, the following
were recorded every 60 minutes: oral
intake, intravenous fluids, and
episodes of vomiting, diarrhea, and
urination. We placed urine collection
bags on children who could not
urinate into measurement containers.
Stool was quantified by weighing
diapers for infants and toddlers and
the use of collection devices for
children who were toilet trained.
Although the WHO tool was employed
to assess dehydration regarding
eligibility, we employed the clinical
dehydration scale (CDS) score23,24
to
perform repeat dehydration
assessments during ED monitoring
because the CDS allows for a better
quantification of dehydration and
thus is better suited to serve as
a covariate during analysis.
Participants were reassessed
24 hours after discharge at their
home or the enrolling institution. If
there were no signs of dehydration
and vomiting and diarrhea had
resolved, 48- and 72-hour follow-up
was done by telephone. For children
with ongoing symptoms or signs of
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4. dehydration, a repeat in-person
reassessment in 24 hours was
required.
Study Outcomes
The primary outcome was
intravenous rehydration defined as
the administration of $20 mL/kg
over 4 hours of an isotonic fluid for
the purpose of rehydration within
72 hours of random assignment. This
outcome was selected because we
sought to include only those who had
an intravenous line inserted for
hydration purposes. It excludes those
who received only maintenance fluids
and those who had the intravenous
line inserted for medication
administration, while capturing those
who received brief bolus fluid
therapy or greater-than-maintenance
fluids for several hours. The 72-hour
time frame balances the potential
benefits and side effects of
ondansetron.
Secondary outcomes identified
a priori were the (1) presence and (2)
frequency of vomiting during the 4-
hour observation period, (3)
hospitalization for .24 hours defined
as the interval from ED arrival to
hospital discharge, (4) volume of ORS
consumed during the 4-hour
observation period, (5) presence of
some dehydration at any time after
discharge up to the 72-hour follow-up
assessment, and (6) number of
diarrheal (ie, loose or liquid) stools
during the 72 hours after random
assignment. The composite outcome
of treatment failure includes
intravenous rehydration, nasogastric
rehydration for .24 hours, or death
within 72 hours. Nasogastric
rehydration was included in our
composite outcome measure because
it is preferred to intravenous
rehydration as second-line
rehydration treatment, after ORT, in
numerous guidelines.25
Statistical Analysis
The planned sample size of 868
patients was estimated to provide
90% power to detect an absolute
between-group difference of 10% in
the risk of receiving $20 mL/kg over
4 hours of an isotonic fluid for the
purpose of rehydration within
72 hours of random assignment (risk
ratio: 0.67) at a baseline risk of 30%
(under the assumption of a 2-sided
5% level of significance) and a lack of
primary outcome ascertainment of
5%. The consensus among
investigators was that the probability
of intravenous rehydration among
children administered the placebo
was higher than the 17% previously
reported by the International Study
Group on Reduced-Osmolarity ORS26
because all study participants have
some dehydration. On the basis of
local expert opinion, sample size
calculations employed a minimally
clinically important difference of
TABLE 1 Baseline Clinical Characteristics of Participants by Treatment Group
Ondansetron, n = 462 Placebo, n = 456
Age, mo 18 (12–30) 18 (12–29)
Male 271 (58.7) 279 (61.2)
Wt, kg 10.0 (8.6–12.0) 10.0 (8.6–12.0)
Chronic medical conditions 0 5 (1.1)
Time interval, last vomit to medication administration, h 1.5 (0.8–2.5) 1.6 (0.8–2.7)
Maximal vomit episodes per 24-h period 5 (3–6) 5 (3–7)
Vomit episodes in past 24 h 4 (3–6) 4 (3–6)
Vomiting duration, d 1 (1–2) 1 (1–2)
Maximal diarrheal episodes per 24-h period 4 (2–6) 3 (2–6)
Diarrheal episodes in past 24 h 3 (2–5) 3 (2–5)
Diarrhea duration, d 1 (1–2) 1 (1–2)
Fevera
122 (26.4) 104 (22.8)
Previous ED visit, current illness 60 (13.0) 62 (13.6)
Previous intravenous rehydration, current illness 20 (4.3) 25 (5.5)
Previous hospitalization, current illness 4 (0.9) 6 (1.3)
Medications administered, past 24 hb
Antacids
Omeprazole and/or ranitidine 4 (0.9) 4 (0.9)
Antipyretics 51 (11.0) 46 (10.1)
Acetaminophen 45 (9.7) 44 (9.6)
Ibuprofen 6 (1.3) 6 (1.3)
Antibiotics and/or antihelminthics 69 (14.9) 60 (13.2)
Azithromycin and/or clarithromycin 1 (0.2) 0 (0)
Amoxicillin and/or ampicillin 1 (0.2) 1 (0.2)
Cefixime and/or cefotaxime/ceftriaxone 31 (6.7) 25 (5.5)
Diloxanide and/or mebendazole 6 (1.3) 10 (2.2)
Metronidazole 41 (8.9) 36 (7.9)
Other 8 (1.7) 3 (0.7)
Antiemetics 97 (21.0) 86 (18.9)
Dimenhydrinate 32 (6.9) 31 (6.8)
Domperidone 76 (16.5) 63 (13.8)
Metoclopramide 1 (0.2) 4 (0.9)
Antihistamines and/or anticholinergics
Cetirizine, clemastine, cyclizine, and/or
diphenhydramine
9 (1.9) 10 (2.2)
Nutrition
Zinc 10 (2.2) 14 (3.1)
Probiotics
Saccharomyces boulardii and/or Lactobacilus
aicdophilus
13 (2.8) 14 (3.1)
Rotavirus vaccine received 201 (43.5) 193 (42.3)
Exclusively breastfed 14 (3.0) 9 (2.0)
CDS score23
2 (2–3) 2 (2–3)
Data are n (%) or median (IQR).
a Fever was defined as an adjusted rectal temperature of $38.0°C. Axillary and oral temperatures were adjusted to rectal
temperatures by adding 1.1°C and 0.6°C, respectively.27
b Some children received .1 medication in the past 24 h.
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5. 10%. Because of delays in data entry
and concerns about completeness, an
additional 50 patients were recruited.
Full outcome data were not available
until the final analysis. All children
randomly assigned were included in
the primary and secondary analyses.
Analyses were undertaken by
intention-to-treat principles. The
proportion of children receiving
intravenous rehydration by 72 hours
was analyzed by using a Mantel-
Haenszel test, stratified by clinical
center and age. Prespecified subgroup
analyses based on subject age,
duration of illness, and baseline
diarrhea and vomiting frequency in
the preceding 24 hours were
conducted. Secondary analysis of the
primary outcome employed
a multivariable logistic regression
model fitted with treatment group
and baseline covariates (ie,
antiemetic, antibiotics, zinc
administration before random
assignment, and the number of
vomiting episodes in 24 hours before
random assignment), which
potentially predict intravenous
rehydration and were associated with
the outcome.
The Mantel-Haenszel test, stratified
by clinical center, was used to analyze
the secondary outcomes of vomiting
(yes or no), hospitalization, presence
of some dehydration recurring within
72 hours, and treatment failure. The
van Elteren test, stratified by clinical
center, was used for the continuous
variables of vomiting frequency,
volume of ORS consumed, and
diarrheal stool frequency.
Because missing baseline values were
present in ,1% of cases, imputation
was not required. A Bonferroni
correction was used to correct for
multiple comparisons, and adjusted P
values are reported. The analysis plan
was prespecified in the protocol and
was performed with SPSS version
22.0 (IBM SPSS Statistics, IBM
Corporation) and SAS version 9.4
(SAS Institute, Inc, Cary, NC).
RESULTS
Among 918 randomly assigned
children (median age, 18.0
[interquartile range (IQR), 12.0–30.0]
months) recruited between June 5,
2014, and December 12, 2017 (Fig 1),
462 were assigned to ondansetron
and 456 to placebo. Baseline
characteristics (Table 1), laboratory
parameters (Supplemental Table 5),
and cointerventions (Table 2) were
similar between groups. The
intervention or placebo medication
was vomited by 3.5% (16 of 462) and
3.7% (17/456) of those in the
ondansetron and placebo groups,
respectively. Primary outcome data
were available for 100% (918 of
918) of study participants; 72-hour
follow-up was completed for 99.9%
(917 of 918; Supplemental Table 6).
Overall, 20.9% (192 of 918) of
children had an intravenous cannula
inserted during the study period
(placebo: 105 of 456 [23.0%];
ondansetron: 87 of 462 [18.8%]; OR:
0.77; 95% confidence interval [CI],
0.56 to 1.07).
Primary Outcome
The administration of $20 mL/kg
over 4 hours of an intravenous
rehydration solution within 72 hours
of random assignment occurred in
14.7% (68 of 462) vs 19.5% (89 of
456) of those in the ondansetron and
placebo groups, respectively (odds
ratio [OR]: 0.71; 95% CI, 0.50 to 1.00;
difference: 4.8%; 95% CI, 0.0% to
9.7%; Table 3). Employing
a multivariable logistic regression
model fitted with the treatment group
and adjusted for the administration of
other antiemetics, antibiotics, and
zinc before random assignment
(Supplemental Tables 7 and 8) and
the number of vomiting episodes in
the preceding 24 hours yielded an OR
of 0.70 (95% CI, 0.49 to 1.00) in favor
of the ondansetron treatment arm.
Antibiotic administration (OR: 1.75;
95% CI, 1.08 to 2.84) and the number
of vomit episodes in the preceding
24 hours (OR: 1.12; 95% CI, 1.06 to
1.19 per episode) were also
associated with intravenous
rehydration (Supplemental Tables 7
TABLE 2 ED and Discharge Cointerventions
Ondansetron
(n = 462), n (%)
Placebo
(n = 456), n (%)
Antacid in the ED 10 (2.2) 26 (5.7)
Omeprazole 10 (2.2) 25 (5.5)
Ranitidine 0 (0) 1 (0.2)
Antibiotic in the ED 114 (24.7) 99 (21.7)
Amoxicillin 5 (1.1) 1 (0.2)
Azithromycin 5 (1.1) 12 (2.6)
Cefixime 28 (6.1) 18 (3.9)
Ceftriaxone 38 (8.2) 39 (8.6)
Ciprofloxacin 20 (4.3) 10 (2.2)
Metronidazole 22 (4.8) 24 (5.3)
Antibiotic recommended at discharge or given after discharge 112 (24.2) 98 (21.5)
Any antibiotics during the whole study period 125 (27.1) 109 (23.9)
Antiemetic in the ED 168 (36.4) 180 (39.5)
Dimenhydrinate 1 (0.2) 2 (0.4)
Domperidone 154 (33.3) 157 (34.4)
Ondansetron 18 (3.9) 28 (6.1)
Metoclopramide 1 (0.2) 1 (0.2)
Antihistamine in the ED
Cetirizine 5 (1.1) 3 (0.7)
Antipyretic in the ED 82 (17.7) 69 (15.1)
Acetaminophen 59 (12.8) 52 (11.4)
Ibuprofen 25 (5.4) 18 (3.9)
Other in the ED
Saccharomyces boulardii 119 (25.8) 117 (25.7)
Zinc 84 (18.2) 73 (16.0)
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6. and 8). There was no evidence of
interaction between treatment
group and age (Fig 2), presence
of $3 diarrheal stools in the
preceding 24 hours, or presence of
$3 vomits in the preceding 24 hours
(Table 4, Supplemental Tables 9
and 10).
Secondary Outcomes
Overall, 13.2% (61 of 462) of
children in the ondansetron group
vomited during the 4-hour
observation period compared with
26.1% (119 of 456) in the placebo
group (OR: 0.43; 95% CI, 0.31 to 0.61;
difference: 12.9%; 95% CI: 7.8% to
18.0%; Table 3, Fig 3). There were
fewer vomiting episodes in the
ondansetron group (P , .001;
Table 3) but no difference in the
volume of oral fluids consumed
during the observation period. The
proportion of children hospitalized
.24 hours and that had some
dehydration develop at any time up
to 72 hours after discharge did not
differ between groups. The number of
diarrheal stools during the 72-hour
follow-up period and the median
volume of diarrhea during the 4-hour
observation period were similar
between groups. Primary and
secondary outcomes were similar at
both study sites (Supplemental
Tables 9–11).
Adverse Events
No serious adverse events or
admissions to the step-down units or
ICUs were reported. Reported
adverse events were similar between
groups (Supplemental Table 11).
DISCUSSION
In this 2-center trial, young children
with some dehydration were less
likely to receive intravenous
rehydration if they received
ondansetron compared with children
who received the placebo. This effect
stems from the reduction in vomiting
associated with ondansetron
administration. These results are
TABLE 3 Participant Clinical Outcomes by Treatment Group
Data are n (%) or median (IQR) unless otherwise stated. N/A, not applicable.
a P values presented for secondary outcomes are adjusted by using the Bonferroni correction procedure; for secondary outcomes, adjustment was performed for 7 comparisons; for
other outcomes, adjustment was performed for 11 comparisons. Statistical tests performed were either the van Elteren test stratified by enrollment center and age (,18 and $18
mo) (continuous variables) or the Cochran-Mantel-Haenszel test stratified by enrollment center and age (,18 and $18 mo) (categorical variables).
b Hospital length of stay was defined as a total length of stay from the ED arrival until discharge.
c Dehydration status was assessed employing the WHO dehydration assessment approach.
d Diarrhea was defined as loose or liquid stools.
e Treatment failure is a composite outcome measure that includes children who experienced any of the following: intravenous rehydration ($20 mL/kg per 4 h), nasogastric
rehydration for .24 h, death within 72 h from any cause, in or out of hospital. No children experienced the outcome of death or nasogastric rehydration.
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7. important because .500 000
children continue to die each year
from AGE,1
and most deaths in LMICs
could be prevented by the use of
known and cost-effective
interventions.28
The evidence from
this study has the potential to lead to
further evaluations in more rural
contexts where a disproportionate
number of children die.29
It is important to consider our results
in the context of the companion study
that included 626 children without
dehydration in which the authors
identified no benefits associated with
ondansetron administration.15
Participants in the current study were
older, had more frequent vomiting,
and higher CDS scores. They were
thus more likely to benefit from an
effective antiemetic. Although the
absolute reduction in intravenous
rehydration use was lower than
anticipated, the reduction was
significant, and the number needed to
treat is 21. The benefits are
symptomatically meaningful with the
number needed to treat to prevent
vomiting being 8. Because these
benefits are in keeping with findings
FIGURE 2
Impact of age in 6-month increments on the primary outcome. IVF, intravenous fluid.
TABLE 4 A Priori Specified Subgroup Analysis of the Primary Outcome
n Ondansetron, n (%) Placebo, n (%) OR (95% CI) Pa
Baseline diarrhea episodes in a 24-h period
$3 episodes 556 50 (17.4) 60 (22.3) 0.75 (0.49 to 1.15) ..99
,3 episodes 362 18 (10.3) 29 (15.5) 0.58 (0.31 to 1.10) .57
Age
,18 mo 449 34 (15.2) 49 (21.7) 0.62 (0.38 to 1.02) .35
$18 mo 469 34 (14.2) 40 (17.4) 0.81 (0.49 to 1.34) ..99
Baseline duration of illness
,48 h 475 38 (15.5) 34 (14.8) 1.07 (0.65 to 1.78) ..99
$48 h 443 30 (13.8) 55 (24.3) 0.46 (0.28 to 0.71) .02
The statistical test performed was the Cochran-Mantel-Haenszel test stratified by the enrollment center.
a P values presented are adjusted by using the Bonferroni correction procedure for 6 comparisons.
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8. from high-income countries where
the absolute reductions in vomiting
and intravenous rehydration are 25%
and 19%, respectively,30
ondansetron
use may be considered to promote
ORT success in children similar to
those enrolled in our study.
The lower than anticipated
intravenous rehydration rate likely
relates to the baseline frequency of
vomiting, which was lower than
anticipated. The median frequency of
vomiting in the preceding 24 hours
was only 4; other reports have
exceeded 9.13,31
The connection
between ondansetron benefits and
vomiting frequency is highlighted by
our multivariable regression model
that retained vomiting frequency as
an independent predictor of
treatment failure. Although it is also
possible that concomitant antiemetic
administration (ie, domperidone)
may have played a role, authors of
most studies have found it to be
ineffective.7,8
Additionally, it may be
that in this academic tertiary care
center, there was greater adherence
to guidelines with an emphasis on
ORT, and the use of higher
thresholds for intravenous
rehydration may be in routine use
than in earlier reports.
In Delhi, India,17
25% of children
with some dehydration who were
administered the placebo received
intravenous fluids compared with
14% of children who were
administered ondansetron (relative
risk: 0.56). Benefits attributed to
ondansetron administration included
expedited resolution of dehydration,
reduced vomiting, and greater
satisfaction.17
Thus, our findings,
supported by previous LMIC work17
and evidence from high-income
countries,10
lead to the conclusion
that despite being of borderline
statistical significance,32
it is highly
likely that ondansetron
administration to children with
dehydration is beneficial in resource-
poor settings. Identification of an
effective antiemetic in this setting is
important because although
domperidone has been revealed to be
ineffective at treating gastroenteritis-
associated vomiting,7,8
it is routinely
employed in LMICs. This is likely
because of the propensity for self-
medication in LMICs,33
the desire to
treat vomiting in children with
dehydration, and the widespread34
belief that domperidone is
effective.8,35
Because both
ondansetron and domperidone are
readily available in Pakistan,
educational efforts disseminating
recent evidence are needed to
improve care.
Antibiotic use was common in our
study. It is indicated in recent reports
in the region that antimicrobial
agents are prescribed to nearly 40%
of children with acute watery
diarrhea due to viral pathogens and
60% of unknown etiology.36
The
excessive use of antimicrobial agents
in Southeast Asia has led to
a resistance crisis.37
Our findings
further these concerns with use also
being associated with increased
intravenous rehydration usage (OR:
1.75; 95% CI, 1.08 to 2.84), which
may reflect the propensity of
antibiotics to cause diarrhea in
exposed children.38
Although we had intended to conduct
stool microbial analyses, because of
an insufficient number of specimens
submitted, this objective was not
completed. Although not different
between groups, the extensive
coadministration of antiemetics such
as domperidone was not anticipated.
Although a more restrictive approach
to concomitant medication use could
have been employed, we focused on
conducting a pragmatic real-world
trial.39
Although, in theory,
concomitant antiemetic use could
have influenced the outcomes of the
study because this was a randomized
clinical trial, it is unlikely to have
altered the effect of the intervention.
Moreover, we incorporated this
covariate in regression models to
further minimize any impact it may
have had. It should be noted that
dehydration assessment using clinical
scores is suboptimal.40
Although
concerns have been raised regarding
use of the WHO dehydration tool,41
in
keeping with local standards of care,
we used it to determine eligibility.
The CDS score23,24
was used to assess
dehydration as an outcome because,
unlike the WHO tool, it can be
employed as a quantitative tool.
Future studies investigating
FIGURE 3
Number of vomiting episodes during the 4 hours after study drug administration.
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PEDIATRICS Volume 144, number 6, December 2019 11
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12. DOI: 10.1542/peds.2019-2161 originally published online November 6, 2019;
2019;144;
Pediatrics
Emaduddin Siddiqui, Jianling Xie, Fady Dawoud and Zulfiqar A. Bhutta
Stephen B. Freedman, Sajid B. Soofi, Andrew R. Willan, Sarah Williamson-Urquhart,
Randomized Clinical Trial
Oral Ondansetron Administration to Dehydrated Children in Pakistan: A
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